SNaPR01: Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT03952520
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Ohio State University (Other), Johns Hopkins University (Other), Hanoi Medical University (Other), Vietnam Administration for HIV/AIDS Control (VAAC) (Other)
6,242
1
2
33.7
185.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two implementation approaches [Standard Approach (SA) vs. Tailored Approach (TA)] for scaling-up the evidence-based systems navigation and psychosocial counseling integrated intervention (SNaP) in HIV test sites in Vietnam.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard Approach (SA)
  • Other: Tailored Approach (TA)
N/A

Detailed Description

This is a cluster randomized, controlled implementation trial to compare two implementation approaches (standard and tailored) for scaling-up the SNaP intervention in 42 HIV test sites in Vietnam. The SNaP intervention combines systems navigation and psychosocial counseling for people who inject drugs (PWID), and it is designed to facilitate PWID's engagement in HIV and substance use care.

The two implementation approaches being compared are:
  • Standard Approach (SA); vs.

  • Tailored Approach (TA)

SNaP is an evidence-based intervention (EBI) that combines systems navigation and psychosocial counseling to facilitate the engagement of HIV-infected people who inject drugs (PWID) into HIV and substance use care.

The 42 HIV test sites will be randomized in a 1:1 ratio to either the standard approach (SA) procedure or a tailored approach (TA).

At the HIV test sites, the study will enroll:
  • Approximately 6200 HIV-infected PWID who are newly diagnosed and not currently on antiretroviral therapy (ART), who consent for medical record assessments. Of those PWID enrolled, a subsample cohort of 1500 PWID will also be enrolled for detailed assessments, including viral load determination, at baseline, 12 and 24 months.

  • HIV test site director boards and staff.

Study activities will span across 5 years, with approximately 27 months at each site and recruitment of PWID participants over 21 months. For PWID not in the subsample cohort, participation is a one-time visit. For the subsample cohort PWID or PWID selected for qualitative interviews, maximum study participation time is 24-27 months. For HIV test site director boards and staff, maximum time in the study is 24-27 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Scaling up HIV Prevention Trials Network (HPTN) 074: a Cluster Randomized Implementation Trial of an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam
Actual Study Start Date :
Jun 10, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Approach (SA)

The Standard Approach is a one-size-fits-all multifaceted implementation strategy that was systematically developed using Intervention Mapping.

Other: Standard Approach (SA)
The multifaceted implementation strategies for SA sites were identified through centralized Intervention Mapping. Before SNaP implementation starts, the specific set of one-size-fits-all implementation strategies was determined through a formal process with investigators, government stakeholders, and clinical representatives.

Experimental: Tailored Approach (TA)

The Tailored Approach includes an implementation strategy that will be tailored to match site-specific barriers to implementation of SNaP at that site.

Other: Tailored Approach (TA)
The Tailored Approach includes the multifaceted strategy that will be offered to the Standard Approach condition. It will also be tailored to match site-specific barriers to implementation of SNaP at that site. The strategy for TA sites involves a 2-day site-specific training, monthly coaching calls, and an external technical assistance hotline to help organizations to tailor implementation strategies to address their site-specific needs. At the 2-day TA training, the TA sites will be guided on developing site-specific implementation plans, in which they may use additional implementation strategies that they have identified themselves or selected from a list developed by the central team.

Outcome Measures

Primary Outcome Measures

  1. Fidelity to SNaP Intervention Procedures [24 months after SNaP implementation]

    Fidelity measures whether the SNaP intervention was delivered as intended. Fidelity score = (% Systems navigation sessions completed x Average navigation session quality score) + (% Counseling sessions completed x Average counseling session quality score) Session completion will be assessed by reviewing the navigator and counselor logs, while session quality will be assessed by central implementation team review and scoring of a random 10% of all forms (navigation) and audio-recordings (psychosocial counseling). Test site fidelity score range: 0-200 (Higher score indicates higher fidelity.)

  2. % PWID Who Initiated ART [24 months after SNaP implementation]

    % of PWID who initiated ART among the PWID who received SNaP, measured through ART clinic records of consenting PWID. This measures ART uptake among PWID who received the SNaP intervention.

Secondary Outcome Measures

  1. % PWID Who Were Contacted and Participated in SNaP [24 months after SNaP implementation]

    Penetration of SNaP at the test sites is assessed by this measure. Penetration of SNaP is defined as the proportion of newly diagnosed or previously diagnosed and not currently on ART PWID at test sites who are contacted by a navigator and/or counselor and participate in a SNaP session.

  2. Acceptability of SNaP by PWID and Test Site Staff [24 months after SNaP implementation]

    Acceptability is the perception that the SNaP intervention is agreeable, palatable, or satisfactory to PWID and test site staff. Acceptability among PWID participants will be assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items containing responses on a 5-point Likert scale. The AIM score will be the sum of the 4 item responses. Acceptability among site staff will be assessed using the Ottawa Acceptability of Decision Rules Instrument (OADRI), a 12-item scale, staff and client acceptability of an innovation in a clinic setting. Higher AIM and OADRI scores indicate higher acceptability.

  3. % PWID Who Are Virally Suppressed [24 Months after SNaP implementation]

    % of PWID who are virally suppressed among the PWID who received SNaP Viral suppression is defined as undetectable viral load. (This outcome will be measured only in the PWID subsample cohort.)

  4. % PWID on Medication-Assisted Treatment (MAT) [24 Months after SNaP implementation]

    % of PWID on MAT among the PWID who received SNaP, measured through MAT clinic records of consenting PWID. This measures MAT uptake among PWID who received SNaP.

  5. Incremental Cost-Effectiveness Ratio of SA Compared to TA for SNaP Implementation [24 months after SNaP implementation]

    The incremental cost per incremental ART uptake, comparing TA to SA, measured as: The difference in costs of implementing SNaP in TA compared to SA sites divided by the difference in ART uptake in TA compared to SA sites.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
PWID participants:
  1. HIV infection:
  • Newly diagnosed HIV infection, based on confirmatory test, and not currently on ART at the time of study enrollment; or

  • If previously diagnosed with HIV infection, then must not currently be on ART at the time of study enrollment (self-reported)

  1. Age 18 years or older

  2. Injection drug use within the past 6 months (self-reported at time of screening)

  3. Willing to provide informed consent for the study

Test site director boards and staff:
  1. All test site director boards and staff, including the navigators and counselors, at the selected HIV test sites

  2. Willing to provide informed consent for the study

Exclusion Criteria:
PWID participants:
  1. Residence outside of the catchment area of local antiretroviral therapy (ART) and medication-assisted treatment (MAT, e.g. methadone) clinics

  2. Currently on ART at time of study enrollment (self-reported)

  3. Planning to move out of the catchment area within the next 24 months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanoi Medical University Hanoi Vietnam

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • National Institute on Drug Abuse (NIDA)
  • Ohio State University
  • Johns Hopkins University
  • Hanoi Medical University
  • Vietnam Administration for HIV/AIDS Control (VAAC)

Investigators

  • Principal Investigator: Vivian F Go, PhD, MPH, MA, University of North Carolina, Chapel Hill
  • Principal Investigator: William C Miller, MD, PhD, MPH, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03952520
Other Study ID Numbers:
  • 18-2901
  • 1R01DA047876-01
  • IGHID 11844
First Posted:
May 16, 2019
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022